In today's rapid technology-driven digital transformation, Pharma and Life Sciences companies face numerous challenges with GxP Computer Systems Validation. Determining an appropriate validation strategy, having the right resources, streamlining validation test execution and gaining comprehensive quality, risk and compliance oversight have been some of the key drivers for organizations to seek out promising alternatives to establish and demonstrate audit ready regulatory compliance.
Being a highly regulated industry sponsors find it cumbersome to generate and maintain complex validation documentation and related evidence. As most validation processes are manual and paper-based, the outcomes usually have compliance deficiencies, higher cost, and more significant opportunity for errors.
How We Can Help
Techsol provides a highly specialized and comprehensive validation-as-a-service (VaaS) offering to eliminate compliance risks and reduce the risk-burden with ongoing change management of GxP critical process management systems, data platforms and related applications. With a dedicated focus on Quality, Risk, Patient Safety and Regulatory Compliance, our validation-as-a-service is aimed towards delivering value by providing:
Over the last 10+ years, Techsol has enabled several global biopharma and medical device companies to strategize, plan, and execute rapid GxP system implementation with comprehensive quality and compliance assurance. Our team of validation SMEs have extensive domain expertise and in-depth knowledge on global and regional GxP regulations such as FDA’s 21 CFR Part 11, EMA, ICH-GCP, GDPR, HIPAA, etc.
We have enabled our clients to launch their GxP operational systems faster using our proprietary validation accelerator which is engineered based on industry best-practices such as the GAMP-5 risk-based approach, ITIL, and Total Quality Management frameworks.
Our GxP validation accelerator has been used by clients across the following areas:
- Clinical Systems Validation
- Drug Safety Platform Validation
- Equipment and Instrument Validation
- Lab Validation
- Process Validation
- Data Analytics Validation
- Medical Device Qualification and Assurance
- Automation Validation
News & Updates
Food & Nutraceuticals: How Companies can Prove Health Value with Clinical Trials
What are Food and Nutraceuticals? ‘Nutraceuticals’ is a composite term of ‘nutrition’ and ‘pharmaceutical’. They are a blend of products that possess both nutritional as well as medicinal value. They are designed to improve physical health, boost immunity, and deal with stress and increase longevity. Nutraceutical products play a significant role in maintaining normal physiological [...]
Best Practices for Signal Management in Pharmacovigilance
Pharmacovigilance involves the collection, detection, assessment, and monitoring of data on Adverse Drug Reactions (ADRs) which must be evaluated to derive vital safety information. Signal detection involves monitoring the adverse reaction data for patterns that suggest new safety information. Safety signals can be detected from an extensive range of sources, such as spontaneous reports, clinical [...]
Enabling eSource in Clinical Studies to Optimize Trial Quality
Source data is all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. The electronic data source or eSource is the data that is initially recorded in electronic format in this process. Biopharma and [...]